Alveolar Bone Resorption, Sequela, Tooth Extrusion
Conditions
Keywords
Sinus pneumatization, Socket preservation, Sinus augmentation
Brief summary
Hard and soft tissue deficiencies of an alveolar ridge arise as sequelae of tooth extraction when socket preservation is not applied. In addition, extraction of posterior maxillary teeth causes pneumatization of the maxillary sinus in relation to other fixed landmarks such as the teeth. These anatomic sinus limitations and alveolar bone deficiencies are the main challenges for dental implant placement. Different bone substitutes have been used to augment bone in pneumatized maxillary sinuses. Scaffolding materials such as xenografts or synthetics substitutes have been proven to be a viable alternative. Xenografts are obtained from nonhuman species and serve as a scaffold for the formation of new bone (osteoconduction). Histologic evaluation of maxillary sinuses grafted with xenografts revealed newly formed bone to be mostly woven bone with some remodeling to lamellar bone. These histologic findings reaffirm the osteoconductive ability of xenografts when used as the sole grafting material in maxillary sinus augmentation. Xenografts appear to be an effective method for maxillary sinus grafting and demonstrate limited resorption over time. Sinuses augmented with synthetic bone substitute (SBS) also appear to successfully integrate based on recent histomorphometric studies. Vascularization and trabecular bone formation in sinuses grafted with SBS has been previously demonstrated. One type of SBS includes porous granules of bioactive and resorbable silica-calcium phosphate nanocomposite (ShefaBone). ShefaBone grafts offer a novel alternative that can potentially unite the 3 salient bone-forming properties (osteoinduction, osteoconduction, and osteogenesis). ShefaBone has unique properties including: 1) bioactivity 2) bioresorbablility, and 3) allowing for the uptake of calcium ions from the physiological solution and releasing phosphate and silicate ions which aid in bone formation. A material with such properties will substitute bone in a more controlled and effective combination that can be obtained in many clinical situations, without the disadvantages found with autograft. ShefaBone has demonstrated successful regenerative properties for bony defects. To our knowledge, there is no reported clinical studies on the use of SCPC material to graft a pneumatized maxillary sinus. This aim of this current study is to compare SCPC to commonly used xenograft material in an augmented maxillary sinus.
Detailed description
1. To assess the quality and quantity of the maxillary sinus bone prior to the placement of dental implants and subsequent restorations, approximately 20 patients will be randomly assigned to receive an augmentation of the maxillary sinus region using either Shefabone (synthetic bone) or Bio-Oss (xenograft). 2. With the use of pre-operative and post-operative limited view CBCT (cone-beam computed tomography) radiography, the maxillary sinus bone density will be assessed and compared between the individuals receiving Shefabone and the individuals receiving xenograft material. 3. Histomorphometric analysis will be used to assess, compare and contrast the quality and the quantity of the new vital bone cells generated when using these different graft materials.
Interventions
Silica-calcium phosphate composite.
Xenograft Bone substitute. Bone from animals.
Sponsors
Study design
Intervention model description
Randomized controlled clinical trial. Entails 2 groups of subjects which will be randomly assigned. Group 1 will be the control group, and group 2 is test group.
Eligibility
Inclusion criteria
* 20 to 75 years of age * at least one maxillary edentulous posterior site requiring maxillary sinus grafting and replacement with a dental implant.
Exclusion criteria
* current smokers/tobacco users * are pregnant * have active periodontal disease * have uncontrolled diabetes * have any autoimmune disease * have kidney disease * have liver disease * are receiving radiation or chemotherapy * have any type of radiographic periapical pathology such as a periapical abscess.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bone Density - Limited View CBCT (Cone-beam Computed Tomography) Measurements | 5 months | Bone density will be measured by limited view CBCT radiography pre- and post-operatively. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bone Quality | 5.5 months | Bone quality will be measured using histomorphometric analysis. |
Countries
United States
Participant flow
Pre-assignment details
24 participants were consented for the study but 2 did not meet eligibility criteria and did not receive an intervention
Participants by arm
| Arm | Count |
|---|---|
| Control Group Control group in this study will comprise of 10 subjects and will receive Bio-Oss xenograft bone material.
Bio-Oss: Xenograft Bone substitute. Bone from animals. | 15 |
| Test Group The test group in this study will comprise of 10 subjects and will receive Shefabone synthetic bone substitute.
Shefabone: Silica-calcium phosphate composite. | 7 |
| Total | 22 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Control Group | Test Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 8 Participants | 2 Participants | 10 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants | 5 Participants | 12 Participants |
| Age, Continuous | 62.7 years STANDARD_DEVIATION 12.4 | 63.4 years STANDARD_DEVIATION 9.9 | 62.9 years STANDARD_DEVIATION 11.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants | 7 Participants | 22 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 14 Participants | 6 Participants | 20 Participants |
| Region of Enrollment United States | 15 participants | 7 participants | 22 participants |
| Sex: Female, Male Female | 8 Participants | 2 Participants | 10 Participants |
| Sex: Female, Male Male | 7 Participants | 5 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 7 |
| other Total, other adverse events | 0 / 14 | 0 / 7 |
| serious Total, serious adverse events | 0 / 14 | 0 / 7 |
Outcome results
Bone Density - Limited View CBCT (Cone-beam Computed Tomography) Measurements
Bone density will be measured by limited view CBCT radiography pre- and post-operatively.
Time frame: 5 months
Population: Data was incomplete for 4 subjects due to poor diagnostic quality or missed appointment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Bone Density - Limited View CBCT (Cone-beam Computed Tomography) Measurements | 14.4 percentage of bone height shrinkage | Standard Deviation 3.9 |
| Test Group | Bone Density - Limited View CBCT (Cone-beam Computed Tomography) Measurements | 1.5 percentage of bone height shrinkage | Standard Deviation 8 |
Bone Quality
Bone quality will be measured using histomorphometric analysis.
Time frame: 5.5 months
Population: Data was incomplete for 4 subjects due to poor diagnostic quality or missed appointment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Bone Quality | 60 percentage of mineralized bone formation | Standard Deviation 0 |
| Test Group | Bone Quality | 100 percentage of mineralized bone formation | Standard Deviation 0 |